Shimadzu X-ray TV System — Class II medical device recall Z-0917-2017
Terminated recall by Shimadzu Medical Systems, reported 2017-01-04, distributed in AR, CA, CT, FL, GA, IA, IL, IN…. Shimadzu Medical Systems is recalling Shimadzu X-ray TV System SONIALVISION due to possibility of oil leaking
| Recall number | Z-0917-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shimadzu Medical Systems, Torrance, CA, United States |
| Recall initiated | 2016-11-20 |
| Classified | 2016-12-23 |
| Reported by FDA | 2017-01-04 |
| Terminated | 2017-12-11 |
| Distributed | AR, CA, CT, FL, GA, IA, IL, IN, MD, MT, NE, NV, NY, OH, OR, PA, SC, SD, TX, WA |
| Quantity | 39 units |
| Reason classes | packaging |
| Serial numbers | 41C351641001, 41C351641002, 41C351641003, 41C351643001, 41C351646001, 41C351646002, 41C351647001, 41C35164A001, 41C35164B001, 41C35164C001, 41C351651001, 41C351651002, 41C351653002, 41C351653003, 41C351653004, 41C351653005, 41C351654002, 41C351655001, 41C351655002, 41C351655003, 41C351656001, 41C351659001, 41C35165A001, 41C35165A002, 41C35165A003 and 14 more |
Product
Shimadzu X-ray TV System, Catalog No. SONIALVISION G4
Reason for recall
Shimadzu Medical Systems is recalling Shimadzu X-ray TV System SONIALVISION due to possibility of oil leaking from the x-ray tube housing under certain conditions.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.